Means and methods for performing an anastomosis

ABSTRACT

An anastomosis is performed using a mounting structure mounted on the outside of at least one vessel. The mounting structure includes a flexible mounting structure that is attached to the vessel by a special instrument. A graft vessel is attached to the mounting structure either directly or by means of another mounting structure attached to the graft vessel. Tools for attaching a mounting structure to a vessel are disclosed, and a tool for attaching two mounting structures together is also disclosed. Methods for carrying out the anastomosis according to the invention are also disclosed.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to the general art of surgery, and to theparticular field of means and methods associated with anastomoses.

BACKGROUND OF THE INVENTION

In the United States, there are currently as many as 300,000 coronaryartery bypass graft (CABG) procedures performed on patients annually.Each of these procedures may include one or more graft vessels which arehand sutured. Until recently, coronary artery bypass procedures havebeen performed with the patients on cardiopulmonary bypass whereby theheart is stopped with cardioplegia and the surgery is performed on anexposed, stationary heart.

The vast majority of CABG procedures performed currently areaccomplished by opening the chest wall to gain access to the coronaryvessels. Through the use of heart lung bypass machines and a drug toprotect the heart muscle, the heart is stopped and remains still duringthe procedure. In this setting, the surgeon has ample time and access tothe vessels to manipulate hand suturing instruments such as forceps,needle holders and retractors.

However, with increasing costs of hospital stays and increased awarenessby patients of other minimally invasive surgical procedures, interest indeveloping a minimally invasive CABG procedure is increasing. Hospitalsneed to reduce costs of procedures and patients would like lesspost-operative pain and speedier recovery times.

In the past, two significant developments in the technology played amajor role in advancing the whole area of cardiac surgery. Theheart-lung machine was invented in the 1950's but underwent significantimprovement in design to become a reliable clinical device in the1960's. The heat-lung machine allows the surgeon to take the heart outof the blood circulation system to work on it in isolation.

The second major development was in myocardial protection. When theheart was isolated from the circulation, it was no longer perfused.After twenty to thirty minutes of ischemia, irreparable damage occurredand no matter how good the repair, the heart function was frequentlyinadequate to allow the patient to survive. Cardioplegia, a solutionwhich is generally cold and high in potassium, changed everything. Thisdevelopment occurred in the 1970's. This allowed very satisfactoryprotection of the heart so the surgeon could perform an unhurried repairand still expect the heart to work afterward.

A secondary consequence of these developments was the decline ininterest in technology to facilitate heart surgery. When speed of thesurgery was initially of utmost importance, all sorts of developmentswere proposed to speed surgery. Therefore, the art in the 1960's and1970's contained numerous examples of such devices.

Now with an increased incentive to reduce costs, there is a renewedinterest in redesigning cardiothoracic procedures. A few pioneeringsurgeons are now performing minimally invasive procedures whereby thecoronary artery bypass is performed through a small incision in thechest wall. There are some surgeons that believe that the best way toperform a minimally invasive coronary artery bypass procedure is toperform the procedure on a beating heart, i.e., without heart-lungbypass and cardioplegia. This minimizes the time it takes to perform theprocedure and reduces the cost of the operation by eliminating the heartlung bypass machine.

In the case of minimally invasive procedures on a beating heart, thesurgeon starts by making a mini-thoracotomy between the fourth and fifthribs and, sometimes, removing the sternal cartilage between the fourthor fifth rib and the sternum. The space between the fourth and fifthribs is then spread to gain access to the internal mammary artery (IMA)which is dissected from the wall of the chest. After dissection, it isused as the blood supply graft to the left anterior descending artery ofthe heart (LAD). Below the IMA lies the pericardium and the heart. Thepericardium is opened exposing the heart. At this point, the LAD may bedissected from the fissure of the heart and suspended up with softligatures to isolate the artery from the beating heart. Some companiesare making a special retractor to gently apply pressure to the heartmuscle to damp the movement right at the LAD. A small arteriotomy isperformed in the LAD and the graft IMA is sutured to the LAD.

Traditionally, to gain access to the cardiac vessels to perform thisprocedure the sternum is sawn in half and the chest wall is separated.Although this procedure is well perfected the patient suffers intensepain and a long recovery.

Until recently all bypass graft procedures have been performed by handsuturing the tiny vessels together with extremely fine sutures undermagnification. The skills and instruments required to sew extremely thinfragile vessel walls together have been perfected over the last twentyyears and are well known to the surgical community that performs theseprocedures.

In the `open chest` surgical setting, the surgeon has adequate accessand vision of the surgical site to manipulate the anatomy andinstruments.

The push for less invasive surgical approaches is fueling interest inmany areas that were abandoned long ago--including that of coronaryfastening and valve replacement. The inventors have thus identified aneed for a device and a method to perform CABG surgery on a beatingheart.

Some surgeons are attempting minimally invasive CABG procedures usingfemoral artery bypass access rather than opening the chest for bypassvia the aorta. However, since use of cardioplegia requires additionalsupport and expense during the anastomosis procedure, the inventorsbelieve that it is best to attempt to fasten the anastomosis while theheart is beating. However, this procedure when performed with a handsuturing technique is very imprecise due to the translation of movementfrom the beating heart to the suspended artery. This may cause impreciseplacement of the suture needles. Any imprecise placement of the suturesmay cause a distortion of the anastomosis which may cause stenosis atthis junction. The sutures used for this procedure are extremely fine(0.001" in diameter) and are placed less than 1 mm apart.

As one can imagine it is difficult enough to place suture needles thesize of a small eyelash into a vessel wall with placement accuracy ofbetter than 1 mm. To accomplish this feat of precision on a movingtarget is extremely difficult. To make matters worse, the site is oftenbloody due to the fact that the heart has not been stopped.

Therefore, there is a need for a means and method which permits theforming of a precise anastomosis without requiring the stopping of abeating heart. Still further, there is a need for performing such ananastomosis in a minimally invasive manner.

The current method of hand suturing is inadequate for the followingreasons:

On a beating heart it may be difficult to place the sutures with theposition precision required. In a beating heart procedure the surgeoncan attempt to minimize the deleterious effects of the movement by usingsuspension or retraction techniques. However, it is impossible toisolate all movement of the vessel during an anastomosis procedure.

Methods that attempt to stabilize and isolate the artery from themovement of the beating heart can damage the vessel or cause myocardialinjury (MI).

In addition to the problem of placing sutures accurately one must makean incision through the artery wall to open the artery. This too is adelicate procedure even on a still heart because the incision must be ofa precise length. It is also critical to not penetrate the back wall orside wall of the vessel which will lead to complications. The placementof the initial incision is of paramount importance. The surgeon mustpick a suitable location free from calcium deposits, fat and sidebranches.

Without cardioplegia, one must also provide blood flow to the heartmuscle while the heart is beating, therefore, after the initialarteriotomy, the surgical field is very bloody and obscured.

Access to the heart vessels other than the LAD will be extremelydifficult with minimally invasive hand suturing due to the anatomicallocation of the posterior wall of the heart.

Although minimally invasive CABG procedures are taking place now withsutured anastomosis they require superlative skills and are thereforenot widely practiced.

One of the most vexing problems is that of adequate access. Theprocedure takes place through an access site created between two ribs.The ribs cannot be spread too far without risk of breaking and the heartlies deep within the chest. The access is through a small, long, darktunnel. The surgeon must then manipulate his tools down this tunnelwithout obscuring his vision.

If special tools are constructed to allow the surgeon to be able to holdsuture needles on the end of a long instrument, the added length of thetool only amplifies any inaccurate manipulation. The same holds true forany special suturing devices contemplated.

If the sutures are not placed correctly in the vessel walls, bunching orleaks will occur. In the minimally invasive procedure this isdisastrous, usually resulting in the conversion to an open chestprocedure to correct the mistake. Any rough handling of the vessel wallsis detrimental as inflammation can cause further postoperativecomplications.

The anastomosis must seal leak tight to prevent exsanguination.Therefore, any improvement over sutures must provide a leak free seal ina very confined space, yet should provide proper flow areas in thevessel after healing is complete.

As is apparent from the above discussion, it is necessary to find a wayto control the beating heart movement of the vessel while performing theanastomosis in such a way that still allows for exact placement of thefastening means.

While the art contains disclosures of several devices that are used tojoin blood vessels, these devices are primarily directed to anend-to-end anastomosis, which is inadequate for CABG procedures.Furthermore, the techniques disclosed in the prior art often require thevessels to be severely deformed during the procedure. The deformationmay be required to fit the vessels together or to fit a vessel to ananchoring device. One cannot just slit the tissue and pull it through aring to anchor it on a flange. Pulling or stretching the vessel wallsproduces a very unpleasant and unexpected result. Vessel walls are madeof tissue fibers that run in the radial direction in one layer and thelongitudinal direction in another layer. In addition the elasticity ofthe tissue fibers in the longitudinal direction is greater than thosethat run radially. Therefore, the tissue will not stretch as easily inthe radial or circumferential direction and results in a narrowing orrestriction when pulled or stretched in the prior art devices. Vesselwalls also have a layer of smooth muscle cells that can spasm if treatedharshly. Such manhandling will result in restrictions and stenoticjunctions because the vessel walls will react poorly to being treated insuch a rough manner and the stretching of the vessel wall will telegraphup the vessel wall due to the high radial stiffness of the vesselstructure, causing restrictions and spasms in the vessel wall. The priorart fails to teach that the vessels are living tissue and must not bemade to conform to rigid fitting-like shapes. Therefore, there is a needfor an anastomotic technique that permits handling of blood vessels in amanner that is not likely to cause those blood vessels to react poorly.

Additionally, prior art systems fail to teach methods of ensuringhemostasis so as not to have leakage under pressure. It is noted thatmechanical devices used to join blood vessels are extremely difficult toseal. No attempt has been made in the prior art to include a hemostaticmedium in conjunction with an anastomotic device. Prior art devices aredirected to accomplishing hemostasis through excessive clamping forcesbetween clamping surfaces or stretching over over-sized fittings.

In order to effect good healing, healthy vessel walls must be broughtinto intimate approximation. This intimate approximation is nowaccomplished by the skilled hands of a surgeon with sutures. A vascularsurgeon is taught how to suture by bringing the vessel edges togetherwith just the right knot tightness. Too loose and the wound will leakand have trouble healing causing excessive scar tissue to form. Tootight will tear through the delicate tissue at the suture hole causingleaks. The key is to bring the edges together with just the right amountof intimate approximation without excessive compression.

It must be further noted that the junctions taught in the prior art arenot anatomically correct both for blood flow and for healing. A wellmade anastomotic junction is not made in a single plane and shouldaccurately follow blood vessel geometry. The junction is more of asaddle shape, and the cross section is not necessarily a circle. Thejunction where the vessel units join is not a constant cross sectionangle, but an angle that varies continuously throughout with respect toany linear reference. In addition, the length of the junction should bemany times the width of the opening in order to assure a low blood flowpressure gradient in the junction and to assure a proper flow area. Infact, the best results are obtained if the confluence area is actuallyoversized. The prior art junctions do not account for such flowcharacteristics and parameters and are thus deficient. Therefore, thereis a need for an anastomotic technique which can establish proper flowcharacteristics and parameters and that accurately preserves bloodvessel geometry, specifically the plural planar nature in which thejunction occurs. Furthermore, most anastomoses are made between vesselsthat are not similar in size. It is therefore necessary to provide ameans and method which allow for the accommodation and joining ofdissimilarly sized vessels.

In addition, the inventors have found through post surgical follow-upthat the supply vessels grow in diameter to accommodate their new rolein providing oxygenated blood to the heart; therefore, there is a needto provide an oversized junction to accommodate any increase in thedimension of the graft vessel size. With a rigid ring that is a singularcircular cross section of the graft, the fitting does not allow thevessel to provide this increase in flow as the vessels expand to meetthe needs of the heart muscle. Still further, the inside lining of thevessel walls (intima) should make contact with each other to have properhealing. The walls of the vessels must come together with just the rightamount of approximation to promote good healing. If the incised edgesare too far apart scarring will occur causing restrictions. The wallscannot be compressed between two hard surfaces which will damage thevessels. The prior art teaches plumbing-like fittings clamped ontovascular structures. However, clamping and compressing the vessel wallstoo tightly will cause necrosis of the vessel between the clamps. Ifnecrosis occurs the dead tissue will become weak and most likely cause afailure of the joint. Still further such rings and tubes used to clampvessels together do not follow the correct anatomical contours to createan unrestricted anastomosis. Failing to account for the way healing ofthis type of junction occurs, and not accounting for the actualsituation may cause a poor result. A suture technique has the advantageof having the surgeon making on-the-fly decisions to add an extra sutureif needed to stop a leak in the anastomosis. In a mechanical minimallyinvasive system it will not be possible to put an `extra suture throw`in so the system must provide a way to assure complete hemostasis. Beinga mechanical system the approximation will not be 100% perfect. Andsince the design errs on the side of not over-compressing the tissuethere may be very small areas that may present a leak between the edgesof the vessel walls. Accordingly healing with prior art techniques usingmechanical joining means is not as efficient as it could be. Therefore,there is a need for an anastomotic technique that accounts for the wayhealing actually occurs and provides proper structural support duringthe healing process.

When vascular integrity is interrupted the body quickly reacts toreestablish hemostasis. Circulating blood platelets are quicklymobilized to the injury site and initiate and support the coagulationsequence that leads to the formation of a fibrin plug at the site ofinjury. Large breaks in vessel walls which are under pressure cannot beeffectively sealed by platelets and fibrin without a substrate tocollect on. It is critical that the junction of an anastomosis bring twohealthy vessel surfaces in close approximation to provide an optimalregion for vessel repair and healing, minimizing the distance betweenhealthy endothelial cells on either side of the junction. This allowsfor the natural control processes which prevent platelet aggregationfrom extending beyond the area of injury. A more detailed description ofthe clot limiting process and the healing process can be found invarious reference texts, such as "Coagulation: The Essentials", byFischbach, David P and Fogdall, Richard P, published by Williams andWilkins of Baltimore in 1981, the disclosure of Chapter 1 thereof beingis incorporated herein by reference.

Still further, some vessels are located or sized in a manner that makesplacing elements thereon difficult. In such a case, the fewer elementsused to perform an anastomosis the better. Therefore, there is a needfor a means and a method for performing an anastomosis that can beeffected without the need of a hemostatic medium.

Many time when a CABG operation is undertaken, the patient has multipleclogged arteries. At the present time, the average number of grafts is3.5 per operation. When multiple grafts are performed, there issometimes the opportunity to use an existing or newly added supplyvessel or conduit for more than one bypass graft. This is known as ajump graft, whereby the conduit, at the distal end thereof is terminatedin a side-to-side anastomosis first, with an additional length ofconduit left beyond the first junction. Then, an end of the conduit isterminated in an end-to-end junction. This saves time and resources andmay be necessary if only short sections or a limited amount of hostgraft material is available.

At the present time, existing means and methods of performing ananastomosis do not permit the formation of multiple anastomotic sites ona single graft vessel such at both proximal and distal ends. Thus asurgeon will have to use multiple tools to perform multiple anastomoses.This will be either impossible or very expensive.

Therefore, there is a need for a means and a method for performing ananastomosis which will lend itself to efficient and cost-effectivemultiple by-pass techniques.

Therefore, there is also a need for a means and a method for performingan anastomosis which will lend itself to efficient and cost-effectivejump graft techniques.

As discussed above, performing a sutured anastomosis in a minimallyinvasive manner while the patient's heart is beating requires anextremely high degree of dexterity. Any instrument used in such aprocedure must therefore be as easy and efficient to use as possiblewhereby a surgeon can focus most of his attention on the anastomosissite. The instrument should thus reflect the above-discussed needs aswell.

Still further, any instrument used in such a procedure must be amenableto efficient manufacture.

OBJECTS OF THE INVENTION

It is a main object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient'sheart.

It is also an object of the present invention to provide an instrumentwhich can be used to efficiently, accurately and effectively form aproper anatomically correct anastomosis.

It is another object of the present invention to provide an instrumentwhich can be used to efficiently, accurately and effectively form aproper anastomosis without stopping the patient's heart.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which the blood vessels are joinedtogether in such a way as to most efficiently promote healing.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which the blood vessels are joinedtogether without squeezing, compressing or otherwise manhandling them.

It is another object of the present invention to provide a method andmeans to stabilize a vessel while performing an anastomotic procedure.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which the blood vessels are joinedtogether to form a confluence area that accurately accounts for flowcharacteristics and flow parameters.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which blood vessels can be joinedtogether in a side-to-side configuration.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which blood vessels can be joinedtogether in an end-to-side configuration.

It is another object of the present invention to provide a means andmethod of performing an anastomosis without stopping the patient's heartin a minimally invasive manner in which blood vessels can be joinedtogether to form a junction that is anatomically correct and accuratelyreflects blood vessel geometry at the junction.

It is another object of the present invention to reduce tissueinflammation and necrosis due to mishandling and over compression.

It is another object of the present invention to provide a means to holdthe edges of the vessel walls in close approximation to promote healingwith a minimum of scarring.

It is another object of the present invention to provide an anastomoticstapling device that provides blood flow to the heart while making theanastomosis.

It is another object of the invention to provide an anastomotic staplingdevice that obviates bunching of the tissue due to imprecise placementof fasteners.

It is another object of the invention to provide an anastomotic devicethat is amenable to efficient manufacture.

It is another object of the present invention to provide an anastomoticmeans and method which can join dissimilarly sized vessels.

It is another object of the present invention to provide an anastomoticmeans and method which will accommodate joining vessel walls at ajunction angle that varies with respect to a reference line.

It is another object of the present invention to provide an anastomoticmeans and method that has a living hinge at a junction site.

It is another object of the present invention to provide an anastomoticmeans and method which can effect a junction without a hemostaticmedium.

It is another object of the present invention to provide an anastomoticmeans and method which can be used in proximal junctions and in multipleanastomotic sites on the same vessel.

It is another object of the present invention to provide an anastomoticmeans and method which can be used in a means and a method forperforming an anastomosis which will lend itself to efficient andcost-effective multiple by-pass techniques.

It is another object of the present invention to provide an anastomoticmeans and method which can be used in a means and a method forperforming an anastomosis which will lend itself to efficient andcost-effective jump graft techniques.

It is another object of the present invention to provide an anastomoticmeans and method which is especially well suited for all types of bloodvessel anastomosis procedures and techniques, such as, but not limitedto, proximal, side-to-side, end-to-side, jump grafts as well as othersthat will occur to those skilled in the art based on the teaching of thepresent disclosure.

SUMMARY OF THE INVENTION

When a patient shows symptoms of cardiac insufficiency which are notsevere enough to warrant surgical intervention, the cardiologist iscalled on to clean out or open up the clogged arteries. One way to openthe artery is to install an internal stent such as disclosed in U.S.Pat. No. 5,425,739. This stent is a prop that is most often configuredlike a cylindrical cage. The stent is delivered to the site over aballoon catheter. When in place, the catheter is inflated, expanding thestent which in turn holds or props open the narrowed artery. Since thestent is made of a material that has no material memory, it will retainthe shape determined by the inflation of the balloon. The balloon isremoved from the artery and the stent stays inside the artery. Suchmemoryless material is suitable for use for a bridge and for thestiffening framework discussed above.

The present invention uses a similar concept, however, the "stent" isexternal to the blood vessel wall. It has the similar function ofholding the vessels open, but is also used as the means for joining thevessels. The external "stent" is the cuff discussed above.

The above-mentioned objects, as well as additional objects as will occurto one skilled in the art based on the teaching of the presentdisclosure, are achieved by a minimally invasive means and method forforming a precise and anatomically accurate anastomosis on a patientwithout requiring the patient's heart to be stopped using an instrumentthat precisely places fasteners on the outside surface of a blood vesselin a position to cause the anastomosis to have a proper flow area and toaccurately reflect the geometry of the junction and which positions theinside edges of the incised blood vessels in abutting contact with eachother whereby proper healing is promoted. The means and method of thepresent invention also provide the ability to create an oversizedjunction which will accommodate future anticipated growth of thevessels. The means and method of the present invention accomplish thiswithout requiring the mishandling of the blood vessels, and can be usedfor side-to-side anastomoses as well as end-to-end anastomoses. Thedevice is also amenable to efficient manufacture.

In addition, these objects are accomplished by providing a flexiblehemostatic medium to hold a malleable stiffening framework. Thehemostatic media can be absorbable material or a fabric material thatallows tissue ingrowth. The medium provides a supportive surface at theedges of the anastomosis for the natural vessel repair process.

Therefore, to address the need of hemostasis, the inventors haveincluded a cuff material which can be made from a variety of materialsto allow the anastomosis to perform in a leak free manner with theproper substrate for healing to occur. It is also anticipated thatthrough more development, a special coating such as collagen coatingscould be incorporated into the hemostatic medium to encourage tissueingrowth, and to discourage excessive thrombosis. Such coatings andtreatments will occur to those skilled in the art based on the teachingof the present disclosure. It is further anticipated that research willsuggest that these media may be absorbable or made from non-wovenfabrics, or combinations of both.

It is therefore shown that the use of a hemostatic medium is a novelapproach to providing a complete minimally invasive anastomotic devicewhich does not use excessive clamping forces.

Although a hemostatic material is shown in the preferred embodiment as awoven synthetic cuff, those skilled in the art will be taught by thisdisclosure to substitute other materials without departing from thescope of the present invention. The term "cuff" can be used to describea form of hemostatic medium but is not meant to be limiting.

The means and method places one or more configurations of hemostaticmedium on the outside surface of blood vessels being joined with theinner edges of the media spaced from the edges of an incision made inthe blood vessel at a distance so no evagination of the vessel occursand no gapping occurs during the healing process. Each cuff is flexibleand can be shaped to match the blood vessel at the junction site. Whenthe cuff or cuffs are closed, the blood vessels are drawn together in amanner which places the inside edge of each of the blood vesselsadjacent to the incisions in abutting contact with each other wherebyproper healing can occur without unduly contorting the blood vessels.The cuff, or cuffs, have a means which permit each cuff to be shaped andto retain the set shape whereby the cuff accurately matches the bloodvessel shape and the junction can be shaped to establish the mostefficient flow conditions.

The present invention can be used to provide an oversized confluencearea so the change in size of the blood vessel to provide oxygenatedflow to the heart can be accommodated. This is done by providing afastener that allows for an oversized length junction and the ability tosize and shape the junction after the two vessels are attached to assurea wide cross-sectional opening between the vessels. Mechanical fastenersor sutures can be used to mount the cuff on the blood vessels. Theprocedure can be performed while permitting virtually uninterruptedblood flow.

The instrument used to attach the cuffs to the blood vessels includes amain body which is adapted to accommodate anvils for both graft vesselsand arteries. The device includes a cuff engaging means for engaging acuff to attach the cuff to the blood vessel and to adjust the shape ofthe cuff to accurately reflect the shape of the junction. A linkageconnects the cuff engaging means to an operating element so a surgeoncan easily operate the device. One of the anvils is received in a graftvessel and the other anvil is received in the artery to which the graftvessel is to be attached. The artery accommodated anvil includes a bloodpassage defining portion so blood can continue to flow through theartery during the procedure. Furthermore, the instrument stabilizes thevessel from the beating heart. The artery accommodated anvil is actuallylarger than the incision in the artery and is "button holed" into theartery via the incision. Once in place in the artery the surgeon canpull up on the vessel at the incision thereby moving the work area inconjunction with the vessel and isolating the work surface from thebeating heart. This makes the cuff fastening accurate and precise. Also,it assures that the tool and the vessel are moving together to isolatethe beating heart movement from the tool.

The device engages the cuff and not the blood vessel so shaping andmovement occurs while applying only minimal and gentle pressure to theblood vessels. This permits the junction to be properly and fullycustomized without mishandling the blood vessels. The instrument alsohas guides for forming the fasteners or staples.

As can be understood from the foregoing, and as one skilled in the artwill be able to understand from the teaching of the present disclosure,the means and method of the present invention can be applied to multiplegrafts and to jump grafts thereby making such techniques possible andcost effective.

While the means and method embodied in the present invention isespecially suited for beating heart surgery, it may also be utilized forminimally invasive procedures that use cardioplegia as well as standard"open chest" procedures due to its novel time saving and precisionfeatures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a schematic showing a heart.

FIG. 2 illustrates a prior art method of locating an incision in anartery for performing an anastomosis.

FIGS. 3, 4, 5A, 5B, and 6-9 illustrate prior art means and methods ofperforming an anastomosis.

FIG. 10 illustrates the principle of the present invention in which ananastomosis includes a hemostatic medium located in such a manner thatclots will form externally of the blood vessel.

FIG. 11 is a side view of a cuff which is included in the means forperforming an anastomosis according to the present invention.

FIG. 11A is a sectional view taken along section line A--A of FIG. 11.

FIG. 12 is an sectional view of the cuff taken along line B--B of FIG.11A.

FIGS. 13A-13F show alternative forms of a cuff.

FIG. 14 is an exploded view showing a singe cuff form of the inventionprior to joining a graft and an artery.

FIG. 15 is a cut away view showing the single cuff form after the grafthas been joined to the artery.

FIG. 16 is an elevational cross sectional view of the single cuff formof the invention joining a graft to an artery.

FIG. 17 is a perspective view of an anastomosis formed using the singlecuff form of the invention in a side-to-side configuration, thoseskilled in the art being able to understand what an end-to-sideconfiguration will look like based on the teaching of the presentdisclosure.

FIG. 18A shows a single cuff form of the invention just prior to drawingthe ends of the two blood vessels together.

FIG. 18B shows the single cuff form of the invention after the ends ofthe blood vessels have been drawn together.

FIG. 19 is an exploded perspective view of one form of the invention inwhich two cuffs are used to join an artery with a graft.

FIG. 20 is a perspective view of a section of the joined artery andgraft using two cuffs.

FIG. 21 is an elevational cross sectional view of the two cuff form ofthe invention in situ.

FIG. 22 is a perspective view of the two cuff form of the invention inan anastomosis which joins a graft to an artery in an end-to-sideconfiguration.

FIG. 23 is a perspective view of the two cuff form of the invention inan anastomosis which joins a graft to an artery in a side-to-sideconfiguration, with the graft being tied off by a suture.

FIG. 24 is an elevational view of another form of the two cuff form ofthe invention showing how the two cuffs are held together whereby thegraft and the artery are pulled together in healing abutment.

FIG. 25 is an exploded perspective view of a tool used in performing theanastomosis according to the present invention.

FIG. 25A is an exploded perspective view of a tool used in performingthe anastomosis according to the present invention, with a cuff inplace.

FIG. 26 is a perspective view indicating the tool in use in placing acuff on an artery.

FIG. 27 is an elevational view of a tool in place in an artery justprior to setting a cuff on the artery.

FIG. 28 is an elevational view of a tool in place after a cuff has beenset onto an artery and just prior to removing an anvil of the tool fromthe artery.

FIG. 29 is an elevational view of a tool with an anvil in place in agraft for placement of a single cuff form of the invention.

FIG. 30 shows a graft vessel prepared to receive a cuff.

FIG. 31 shows a tool holding a cuff prior to placing the cuff on thegraft vessel shown in FIG. 30.

FIG. 32 shows a tool used to cinch a cuff to a graft vessel that hasbeen located in a cuff.

FIG. 33 shows a graft vessel located in a cuff prior to being cinched tothat cuff by the tool shown in FIG. 32.

FIG. 34 shows the tool just prior to setting the means for attaching thecuff to the graft vessel.

FIG. 35 shows an alternative form of a tool for applying a cuff to agraft vessel.

FIGS. 36A-36D show the steps used in applying a cuff to a graft vesselusing the tool shown in FIG. 35.

FIG. 37 shows a tool applying the means for holding the cuff to thevessel in which the means is such that the vessel will not be damaged.

FIG. 38 shows a tool used to join two cuffs together.

FIG. 39 shows the tool used to join two cuffs together docked to onecuff and prior to joining that cuff to another cuff.

FIG. 40 shows the tool docked to one cuff and joining that cuff toanother cuff.

FIG. 41 is a flow chart for the method of performing an anastomosis fora single cuff form of the invention with the vessels being joined in aside-to-side configuration.

FIG. 42A is a flow chart for the method of performing an anastomosis fora double cuff form of the invention with the vessels being joined in aside-to-side configuration.

FIG. 42B is a flow chart for the method of performing an anastomosis fora double cuff form of the invention with the vessels being joined in anend-to-side configuration.

FIG. 43 shows a single cuff form of the invention which has omitted thehemostatic medium.

FIG. 44 shows the continuously varying nature of the junction angle.

FIG. 45 shows the double cuff form of the invention which has omittedthe hemostatic medium.

FIG. 46 shows how the means and method of the present invention can beapplied to a multiple graft technique.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

Locating and performing the arteriotomy

By way of orientation, FIGS. 1 and 2 indicate the locating andperforming of an arteriotomy. As is well understood to those skilled inthe art, locating the position of an anastomosis is extremely importantand extremely delicate. The location must be selected with extremeaccuracy and precision. This is especially so since the blood vesselsare often extremely small. This is indicated in FIGS. 1 and 2 where thelocation of a restriction is indicated as R and an arteriotomy isindicated at I in FIG. 2. The arteriotomy must be made in a properlocation with respect to the restriction R or the surgery will not be aseffective as it could be. Furthermore, an anastomosis must be performedaccurately and effectively to be successful. The present inventiondiscloses and teaches a means and a method of performing such ananastomosis.

Prior Art

Shown in FIG. 3 is an anastomosis involving a artery 10 and a graft 12that is performed according to the prior art. That is, an incision 14 isdefined in artery 10 and a corresponding incision 16 is defined in graft12. Sutures 18 and 20 are set near the ends (heel and toe) of theincisions. Additional sutures are set as indicated in FIG. 4 byreference numerals 1-9 and 1'-9'. Sutures are indicated at 22 and 24.Once the sutures are set, the graft and the artery are drawn together asindicated in FIGS. 5A and 5B.

Ideally, the inside edges of the graft and the artery adjacent to theincisions are placed into abutting contact with each other to promoteproper healing. The inside edge of the graft vessel is indicated in FIG.5A at 26 and the inside edge of the artery is indicated at 26' in thatsame figure. As can be seen in FIG. 5B, the ideal situation has insideedge 26 in abutting contact with inside edge 26' of the artery. However,as discussed above, this is not always the case. While most surgeons areextremely skillful and dexterous, hand suturing is susceptible to errorsand imprecision, especially when the graft and/or artery is extremelysmall. In the case of a minimally invasive surgery, this preciseplacement may be nearly impossible.

As discussed above, some prior art anastomosis techniques have used aring to join two vessels together. This technique is indicated in FIGS.6-9 where ring 30 is placed between two end-to-end vessels in FIG. 6 andrings 30' and 30" are used with two end-to-side joined vessels in FIG.7. The rings serve as the means for holding the joined vessels together.However, the rings have several drawbacks, including evaginating thevessels, restricting the vessels so growth due to higher blood flow isrestricted, and stretching the vessel which causes flattening of thevessel as indicated at portion 32 in FIG. 8. As discussed above, the useof rings suggests that an anastomosis is being viewed as a plumbingconnection between two conduits. As was also discussed above, this issimply not the case with actual blood vessels. As discussed above, iftoo much clamping is applied to the vessels, necrosis may occur.Unhealthy tissue may cause scarring and in fact may fail to heal. Thissituation is illustrated in FIG. 9.

Therefore, the present invention is intended to permit the performanceof an anastomosis in a minimally invasive manner yet to perform theprocedure in an accurate manner and in a manner that promotes properhealing. The most effective healing will occur when the hemostaticmedium is located on the outside of the blood vessel so any clots willform on the outside of the vessel. This basic concept is illustrated inFIG. 10 which shows an anastomotic device AD comprising a hemostaticmedium HM having a stent which includes means FM for fastening the stentto the vessel and which is located on the outside of one blood vessel B1which is to be joined to another blood vessel B2 and for bringing vesselwalls, and the endothelial lining E1, of the one blood vessel intointimate approximation with other vessel walls, represented byendothelial lining E2, of the other blood vessel whereby fibrin clot FCis formed in the proper location to effect a successful procedure. Stillfurther, excessive clamping is avoided in the present invention byobviating the need for clamps, such as are commonly used in prior arttechniques.

Cuff

There are two forms of the invention, a single cuff form (see FIGS.11-18B) and a single cuff form (see FIGS. 19-24). In the interest ofbrevity, this mounting element will be referred to as a cuff. However,no limitation is intended by this shorthand reference.

The single cuff form of the invention has the cuff mounted on the arteryand the graft blood vessel with the vessels being brought into contactwith the vessel attaching elements of the cuff to attach the two vesselstogether. It is here noted that for the sake of brevity, the discussionwill be directed to blood vessels; however, those skilled in the artwill be able to understand that the teaching can be applied to vesselsof any sort that occur in a patient. Accordingly, no limitation isintended by the reference to a "blood" vessel. The double cuff form ofthe invention has one cuff attached to the graft and a separate cuffattached to the artery. These cuffs are then attached to each other toeffect the connection. The single cuff form of the invention has asingle cuff attached to both the graft blood vessel and to the artery,with the single cuff attaching the two blood vessels together to effectthe connection. The double cuff form of the invention has each cuffindividually mounted on a blood vessel by an instrument, and the twocuffed vessels brought together with the cuffs then coupled together.

Shown in FIGS. 11, 11A and 12 is a single cuff 40 embodying the presentinvention. The cuff is applied to a blood vessel and will couple thatvessel to another vessel or to another cuff. The cuff can be applied toa blood vessel by an instrument while blood still flows through thevessel by using a stabilizing cuff application tool with a flow-throughanvil. This enables anastomotic surgery to be performed without stoppingthe heart so the procedure can be carried out in a minimally invasivemanner. The cuff also permits proper shaping of the junction withoutmishandling the blood vessels and places the two vessels in anorientation that promotes efficient healing.

Specifically, cuff 40 includes an oval shaped flexible body 42 having along axis 44 and a short axis 46 with an oval shaped opening 48 definedtherein by the cuff body central section 49. The preferred form of body42 is a woven fabric suitable for use in surgery. A stiffening framework50 of a retention means, such as a malleable material, is integratedinto body 42 for retaining the cuff in a selected shape on a bloodvessel. The preferred form of the retention means is sinuous andincludes a plurality of malleable sections, such as section 52. In thepresent context, this element will be referred to as a retention means.However, as will occur to those skilled in the art based on the teachingof the present disclosure, depending on the context of the discussion,this element can also be referred to as a "stent" or a "stiffeningband." One form of the material is a wire that is suitable for use inthe surgical environment associated with this invention. The retentionmeans has little material memory in that once deformed from one shapeinto another, it will not move back into the first shape from thesecond. A second potential form for the retainer means is shaped fromflat stock which is processed using precise methods such as wire EDM orphoto etching. Shaping the cuff is therefore efficiently carried out bydeforming it into the desired shape after it is mounted on a bloodvessel. The retention means will maintain the cuff in the shapedcondition. Sections of the stiffening framework may be separate fromother sections, such as quartered sections or the like.

Each malleable section has an apex, such as apex 54, with a cuffretaining pin, such as pin 56, thereon. Cuff retaining pins 56 attachthe stiffening framework 50 to the cuff, and anchor means 58 attach base60 of each section 52 to body 42 to securely anchor the stiffeningframework to body 42. However, many cuff pins may be used to secure thecuff frame to the cuff.

Tissue retention pins 62 are attached at a proximal end 64 thereof tothe body 42 and have a distal end 66 which engages a blood vessel toanchor the cuff to that blood vessel in the manner of a surgical staple.The instrument discussed below is used to force the retention pin intothe blood vessel tissue to anchor the cuff to the blood vessel.

Means for shaping the cuff once it is anchored on the blood vesselincludes docking extensions, such as docking extensions 70 having aproximal end 72 unitary with a base of a malleable section of thestiffening framework and a distal end 74 spaced from the outer perimeter76 of the cuff body 42. An eyelet 78 is located on distal end 74 havinga central hole 80 defined therein to engage a corresponding element onthe instrument used to place the cuff. The means for shaping the cuffalso includes a plurality of second docking extensions 82 havingproximal ends 84 integral with alternate apexes of the stiffeningframework 50 and a distal end 86 having an eyelet 88 with a central hole90 for releasable connection to a corresponding element on theinstrument used to place the cuff.

As will be discussed below, the docking extensions are engaged with theinstrument, and once the cuff is anchored to a blood vessel, theinstrument can be manipulated by the surgeon to shape opening 48 to thedesired size and shape. Once the desired size and shape have beenestablished, the cuff and framework is released from the instrument.

As can be seen in FIG. 11, the cuff has an hour glass shape inelevation, with body 42 having a first end section 92 and a second endsection 94 of roughly the same outer dimension, with central section 49having an outer dimension of less than those outer dimensions to definea waist section. Other forms of the single cuff are illustrated in FIGS.13A-13F.

Use of the single cuff form of the invention is illustrated in FIGS.14-18B. The tool for effecting the placement of the cuff and thecoupling of the two vessels will be discussed below in connection withFIGS. 25 et seq. For present purposes, the results will be shown anddiscussed. As shown in FIG. 14, after the graft vessel G and the arteryA have been prepared, the cuff is placed on the artery A. The graftvessel is then moved into proximity of the cuff as shown in FIG. 14 andjoined to the cuff as shown in FIGS. 15 and 16.

As can be seen by comparing FIGS. 18A and 18B, once the cuffs areattached to the blood vessels, the blood vessels are brought together toform the desired connection, and then are shaped so the desired amountof abutting contact is formed between the two adjacent inside bloodvessel edges. To effect the desired amount of abutting contact betweenthe inside edges of the blood vessels, the single cuff form of theinvention can include a means, such as bridge means 110 shown in FIGS.18A and 18B to draw the adjacent blood vessel inside edges 26 and 26'together into abutting contact from the spaced positioning of these twoedges shown in FIG. 18A to the abutting contact shown in FIG. 18B.Bridge means 110 includes a malleable wire 112 or extensions 70, 82,etc. that has essentially no material memory similar to that situationdiscussed above with regard to the stiffening framework 50. Thus, whenbridge wire 112 is deformed from the FIG. 18A configuration to the FIG.18B configuration, it will retain the FIG. 18B configuration therebyplacing the inside edges 26 and 26' in abutting contact with each other.Deformation of wire 112 can be effected with a proper tool. The bridgecan also be formed from shaping pins resistance welded together.

It can also be understood from this disclosure that as the edges of thevessels are brought into intimate contact, there is a defined junctionangle noted by JA in FIG. 18B. This angle varies continuously withrespect to a linear reference, such as the longitudinal centerline ofthe vessels at the junction, as a unit vector associated with the anglefollows around the periphery at the anastomotic junction. The means andmethod of the present invention permits this variation in angle. Thisvariation in junction angle effects a properly shaped anastomosis fordissimilarly sized vessels. This angle will also vary at the heel andthe toe depending on the appropriate angle of the graft vessel, as shownin FIG. 44 at JA', JA" respectively.

By way of reference, a single cuff side-to-side anastomosis is shown inFIG. 17.

The double cuff form of the invention is illustrated in FIGS. 19-24. Ascan be seen (see, e.g., FIG. 21), one cuff 40' is attached to a graftblood vessel G, and a second cuff 40" is attached to the artery A. Ascan be seen in FIG. 19, there is a spacing between the fastening meansattaching the cuff to the vessel and the edge of the artery. Thisspacing is selected so the loose edge of the vessel can still becontrolled, but the fastening means is not located too close to the edgeof the vessel. Bringing the cuffs together in this manner does notmishandle the blood vessels and promotes efficient healing of thejunction. A spacing of 1/2 mm to 1 mm is shown in FIG. 19. However, thisspacing is disclosed for the sake of completeness and is not to be takenas limiting.

Means for joining one cuff to the other in the double cuff form of theinvention includes one unit 98 fixed to the graft (cuff) blood vessel Gand one unit 99 fixed to the artery (cuff) A. As shown in FIG. 19, afemale element 100 is fixed to cuff 40' and a corresponding male element102 is fixed to cuff 40". Female element 100 includes an eyelet 104 thathas an opening sized and shaped to snugly receive male element 106mounted on element 102 to establish a friction fit between elements 100and 102 that securely couples the two cuffs together. The preferred formof the cuff joining means includes four male elements and four femaleelements on each base 98 and 99, each being located on opposite sides ofthe cuffs as is shown in FIGS. 22 and 23. Each cuff has two maleelements and two female elements with the male elements on each basewhereby a secure attachment is effected.

As can be understood by those skilled in the art by comparing FIGS. 21and 16, the double cuff form of the invention uses two cuffs, such as40' and 40", to attach two blood vessels together, whereas, the singlecuff form of the invention uses a single cuff 40'" to attach two bloodvessels together. The double cuff form of the invention has two similarcuffs attached together by a coupling means. The single cuff form of theinvention has a single cuff with the two ends thereof identical eachhaving a stiffening framework therein and each having tissue retentionpins 62'" therein. A single body unitary 42'" forms the cuff 40'".

Both forms of the invention, the single cuff and the double cuff, can beused to form both a side-to-side anastomosis and the double cuff formcan be used to form an end-to-side anastomosis.

The double cuff form of the invention is applied as indicated in FIGS.19-23. A tool, which will be discussed below in connection with FIGS. 24et seq, is used to place a cuff on the graft, and then a second cuff onthe artery. The vessels are then oriented adjacent to each other asindicated in FIG. 19, and then brought together so the two cuffs arecoupled as indicated in FIG. 20. The cuffs are then coupled together asindicated in FIG. 21 to form an end-to-side anastomosis as indicated inFIG. 22 or to form a side-to-side anastomosis as shown in FIG. 23. Thetwo cuffs are coupled together by a suitable fastener, such as theabove-discussed male/female coupling shown in FIG. 21.

An alternative form of the cuff joining means for the double cuff formof the invention is shown in FIG. 24. This form of the cuff joiningmeans includes rivets or staples 114 in place of the male and femaleelements discussed above. The rivets or staples are placed in bases 98and 99 and hold the bases together in the manner discussed above for themale and female elements 104 and 106.

Instrument

As discussed above, the anastomosis technique of the present inventionis intended to be performed in a minimally invasive manner. Therefore,the cuffs discussed above must be placed on blood vessels that arelocated inside a patient, with the artery carrying blood. As was alsodiscussed above, the anastomosis technique of the present invention mayinvolve extremely small blood vessels. Accordingly, the instrument usedto effect the anastomosis must be very accurate and precise, yet willnot mishandle the blood vessels during performance of the technique. Theinstrument will place a cuff on the artery while permitting blood toflow through that artery, and then will place a corresponding cuff onthe graft blood vessel, or will attach the graft blood vessel to thesingle cuff mounted on the artery in the single cuff form of theinvention. The instrument will then be used to shape the cuffs so thejunction is the most efficient and will permit proper healing. All ofthis must be carried out in a minimally invasive manner.

The preferred form of the instrument used to mount a cuff to the arteryin both forms of the invention and to mount the cuff to the artery andto the graft in the double cuff form of the invention is shown in FIGS.25-29, with FIG. 25A showing a cuff in conjunction with the instrument.Instrument 120 broadly comprises a handle frame 122 having a handle 124that is grasped by a surgeon during operation of the instrument, and afinger frame 126 having a finger grip 128 which is operated by thesurgeon, two driver elements 130 and 132 pivotally attached to thehandle frame, a graft anvil 134 and an artery anvil 136.

More specifically, in FIG. 22, handle frame 122 includes a U-shapedsection having legs 140 and 142 attached at one end to handle 124 andwhich are spaced apart to define a channel 144 therebetween. Each leghas an inside surface 146 with L-shaped anvil alignment slots 148 and150 defined in the legs to have short legs 152 that intersect thechannel and long legs 154 defined to be parallel to the channel. Thefunction of the anvil slots will be understood from the followingdiscussion.

The handle frame further includes two ears 156 and 158. The ears includetwo spaced apart plates 160 and 162 with bores 164 and 166 defined ineach plate to be centrally aligned with each other for a purpose thatwill be understood from the following discussion. The handle framefurther includes two rails, such as rail 170, on the outer edges of thelegs 140 and 142.

An undercut region 174 is defined in the proximal end of the handleframe with a top shoulder 176 defined therein at the top entrance tochannel 144. Shoulder 176 is U-shaped and has a channel 178 definedbetween leg 180 corresponding to leg 140 and leg 182 corresponding toleg 142.

Finger frame 122 includes a U-shaped base 184 having two legs 186 eachconnected to a center section 190 and defining a channel 192therebetween. A slot 194 is formed at the intersection of each leg andthe center section, with slots 194 being sized and located to slidablyreceive rails 170. Sliding engagement between the rails and the slotspermits the finger frame to move with respect to the handle framelongitudinally of the channel 190 as is indicated by the double-headedarrow 196, with handle frame 122 moving in direction 198 with respect tofinger frame 126 to open the instrument anvils and moving in direction200 with respect to the finger frame to close the instrument anvils aswill be discussed below.

Each leg 186 of the finger frame 126 further includes an ear, such asear 202 on a distal end thereof to which a guide pin, such as guide pin204, is fixed to extend past the handle frame leg adjacent thereto.

Instrument 120 further includes two pivot pins 206 and 208 accommodatedin the aligned bores 164 and 166. Each of the driver arms 130 and 132has a pivot pin receiving hole 210 and 212 respectively defined in theproximal end of arms 214 and 216 respectively. A crescent-shaped driverelement 218 and 220 is located on the distal end of each arm 214 and 216respectively with a cam slot 222 and 226 being defined in the arms 214and 216 respectively.

The arms are pivotally attached to the handle frame by the pins 206 and208 to move in directions 226 and 228 as indicated by double-headedarrow 230 when finger handle 126 moves directions 198 and 200respectively to open and close the driver heads 218 and 220. Slots 222and 226 slidably receive guide pins 204 to effect this opening andclosing movement. Since the driver arms are fixed at an angle to handleframe 122 by pivot pins 206 and 208 and guide pins 204 movelongitudinally with respect to the handle frame and slidably engage camslots 222 and 226, longitudinal movement of the finger frame withrespect to the handle frame will cause the above-mentioned pivotalmovement of the anvil arms. The opening and closing of the driver armsis illustrated in FIGS. 27 (closing) and 28 (opening).

Each driver head, 218, 220 has a V-shaped cuff-engaging edge, such asedge 232 which is sized and shaped to engage the waist section 49 of acuff. Each edge 232 also has two surfaces 234 that diverge away fromeach other from the edge 232 to engage surfaces 236 and 238 (see FIG.12) respectively of the cuff sections 92 and 94. Engagement of thesurfaces 234 and 236, 238 along with a movement of the anvils 136 and139 forces the tissue fasteners 62 into the tissue of the blood vesselwhile shaping the cuff to the blood vessel.

The tissue fasteners must be turned in the manner of a staple in orderto fully connect a cuff to a blood vessel. Accordingly, instrument 120includes artery anvil 136 and graft anvil 134 which are removablyfixable to the handle frame. Graft anvil 134 includes a body 240 havinga threaded portion 242 on a proximal end thereof, a graft anvil head 244on a distal end thereof and alignment pins 246 between the two endsthereof. A fastening knob 247 is also included with instrument 120, andis internally threaded to threadably engage threaded portion 242.

Knob 247 is accommodated in undercut area 174 and threaded portion 242is extends through channel 178 to be engaged by the threaded portion ofthe fastener 247. Longitudinal movement of the graft anvil in directions260 and 262 is effected by threading the knob 247 on the threadedportion 242. Threaded movement in one direction moves the graft anvil indirection 262 and threaded movement in the opposite direction moves thegraft anvil in direction 260 whereby the location of the graft anvilhead 244 with respect to the driver elements 218, 220 can be adjustedand set. The purpose of this movement will be understood from thediscussion in this disclosure.

A groove in knob 247 engages lip 176 of handle 120. Since knob 247remains stationary the anvil moves up or down to bend or cinch thefasteners 62. Body 240 includes a first portion 248 and a second portion250 that is angled with respect to the first portion 248. Graft anvilhead 244 has a proximal end thereof fixed to portion 250 to extendtransverse to longitudinal centerline 252 of the body 240. The length ofbody 240 as measured between its proximal and distal ends is greaterthan the length of the handle frame as measured along its longitudinalcenterline 252 between the shoulder 176 and distal end 256 whereby graftanvil head 244 is spaced from distal end 256 when the graft anvil 134 ismounted on the handle frame. Arm 248 is also long enough so that graftanvil head 244 is also spaced from driver heads 218 and 220 when thegraft anvil is in place on the handle frame. Alignment pins 246 arereceived through anvil slots 148 and 150 and are slidably accommodatedin slots 154 so the graft anvil is securely and movably affixed to thehandle frame.

Artery anvil 136 includes a body 270 having a threaded portion 272 on aproximal end thereof and an artery anvil head 274 on a distal endthereof. Alignment pins 276 are located on the body to be receivedthrough alignment slots 152 and slidably accommodated in slots 154 onthe handle frame. When the artery anvil is attached to the handle frame,threaded portion 272 extends through channel 178 and is threadablyreceived by knob 247 to attach the artery anvil to the handle frame andto move that artery anvil in directions 260 and 262 with respect to thehandle frame as was discussed above with regard to the graft anvilwhereby the location of the artery anvil head 274 with respect to thedriver heads 218, 220 can be set. The artery anvil head 274 is locatedbeneath the driver heads so that the head can be inserted into an arteryand a cuff being supported by the driver heads will be located outsidethat artery. Once the artery anvil head is positioned inside an artery,the knob 247 is operated to move the anvil head 274 toward the driverheads 218, 220 until the cuff supported in the heads 218, 220 engage theoutside of the artery. The tissue retention pins can then be set.

Artery anvil head 274 includes a bullet shaped body 280 having two ends282 and 284 with a bypass channel 286 defined longitudinallytherethrough from one end 282 to the other end 284. This channel permitsblood flow through the anvil head maintaining perfusion while the cuffis being attached. A fastener turning section 288 is defined in topsurface 290 of the head 274 adjacent to the intersection of the head andthe body 270 and in a location to receive ends 66 of the tissuefastening pins when they are forced through the blood vessel wall. Thefastener turning section is concave so the pin is turned as it engagesand follows the anvil head surface adjacent to the turning section. Thisrotates the fastener end so the fastener is gradually bent from the FIG.7A shape to a curved shape shown in FIG. 25, for example. The tissuefastener is forced to follow this turning section by engagement of thedriver head surface against the cuff and against the fastener body 62 asthe heads 218, 220 are moved into engagement with the cuff by operationof the finger frame 122 and as the artery anvil is moved in direction260 by operation of the knob 247 on threaded portion 272.

Driver heads 218, 220 include docking pins 294 which releasably engageholes 80 and 90 of the docking pins 70 and 82 on the cuff to control theshape of the cuff. The friction fit between pins 294 and the pins 70 and82 is great enough to permit the cuff to be pulled and shaped bymovement of the driver heads, but low enough so the pins 294 can bepulled out of the docking elements without pulling the cuff off of theblood vessel. Alternatively, pins 294 could be retracted through aflexible shaft connected up to the handle. Pulling the driver headsoutwardly in direction 226 will enlarge the junction and will change itsshape from oblong toward circular. Therefore, a surgeon can shape thejunction in the manner that is most efficient to healing and to definingan effective anastomosis.

An assembled instrument is shown in FIG. 26 with an artery anvil beinginserted through an incision I in an artery A and a cuff 40 on thedriver elements. As can be seen, once the incision is made, the arteryanvil head is button holed into the artery via the incision. The anvilhead is actually larger than the incision in the artery but can beangled through the incision into position as shown in FIG. 26. The knob247 is operated to draw the anvil head and vessel surface at theincision up toward heads 218, 220. This action also isolates the workingarea from motion associated with the beating heart. As indicated in FIG.27, after the head supported cuff contacts the outside of the artery,driver heads 218, 220 are operated to force the edges 232 against thewaist 49 and against the surfaces 236 and 238, and the knob 247 isfurther operated to draw the anvil and the cuff together. Furtheroperation of the knob 247 forces the tissue fasteners through the bloodvessel tissue, into turning section 288 and around on themselves in themanner of a staple whereby the cuff is fixed to the blood vessel. Duringthis operation, blood flows through the artery via channel 286. Once thecuff is attached to the artery, the driving heads 218, 220 are opened asshown in FIG. 28 so the anvil head 280 can be removed from the artery.Since the cuff is connected to the driver heads, opening the driverheads will enlarge the incision thereby permitting the artery anvil tobe removed.

The graft vessel is prepared in a similar manner. The graft anvil isinserted into the graft blood vessel via the end of that blood vesseland is tied to the graft anvil head 244 with a garroting suture. Thegraft anvil 134 is attached to handle frame 122. The instrument isoperated to attach a cuff to the graft blood vessel in a manner similarto that just described for attaching a cuff to the artery. Actually, thegraft is prepared first because the surgeon has more time to work on thegraft than on the artery. The graft anvil allows the surgeon to preparethe graft on the anvil first and then attach the anvil to the instrumentat a later time when it is convenient to do so.

The instrument is then maneuvered so the graft blood vessel is adjacentto the cuff mounted on the artery. The knob 247 is then operated toforce the graft blood vessel into contact with the cuff portion that isnot attached to the artery to attach the graft vessel to the arteryattached cuff. As shown in FIG. 29, the graft anvil head has a fastenerturning section 296 which operates to turn the fasteners in that sectionof the cuff in a manner identical to the above-described turning of thefasteners in the artery. This is illustrated in FIG. 29 for a singlecuff embodiment. Turning section 296 is used to turn the tissueretention pins to either attach a single cuff to the blood vessel or toattach a separate cuff to the blood vessel. Once the cuff is attached tothe graft (for the single cuff embodiment), or the cuff on the graft isattached to the cuff on the artery (for the double cuff embodiment) byattaching the coupling elements 106 and 104 (for the double cuff form)or the bridges 110 are manipulated to bring the inside edges 26 and 26'of the vessels together, the driver heads 218, 220 are manipulated toenlarge the graft incision to permit the graft anvil head to bewithdrawn from the graft vessel via the end of that vessel. The driverheads can then be further manipulated to size and shape the junction,and then manipulated to remove the docking pins 70 and 82 from the anvilpins 294 to release the cuff or cuffs from the instrument. The garrotsuture is cut and the graft anvil is removed from the graft. The graftblood vessel is then tied off and the anastomosis is complete.

Instrument for mounting a cuff on the graft artery Shown in FIGS. 30-34is one form of an instrument used to mount a cuff on a graft artery. Analternative form of the instrument is shown in FIGS. 35-37.

As shown in FIG. 30, a graft G is prepared by defining an incision IGtherein. The graft has been removed and is being prepared and cuffedoutside of the patient. An instrument 300 is shown in FIG. 31 andincludes tongs 302 and 304 having cuff-engaging ends 302' and 304'respectively, and handles 302" and 304" respectively which are grippedby the surgeon. A pivot 306 is located at the intersection of the tongs.Each of the tongs has a cutout portion which conforms to one-half of theshape of a cuff whereby a cuff will be securely held in the tongs asindicated in FIG. 31. Elements 106'" are located on the tongs to engagethe female elements on the cuff to hold the cuff in position on thetongs. As can also be seen, each tong has a cutout section 310 forengaging anvil 312 shown in FIG. 32.

Anvil 312 includes a central section 314 having an opening defined in atop section 316 thereof. A section 318 includes two side sections 324and 322, each of which has a cutout, such as cutout 326 in side 322,defined therein. Anvil 312 further includes a threaded element 328extending through the opening defined through top section 316 and ispivotally attached to section 318 at 329. Threaded element 328 isthreadably received through a threaded opening 326' defined throughsection 336. A knob 330 is unitary with the threaded element 328.Rotation of the knob moves top section 318 relative to arms 334 asindicated by double-headed arrow 332. Arms, such as arm 334 have topsection 336 engaging the threaded element 328. Movement of the threadedelement causes the hook sections 338 to move into and out of thecutouts.

As shown in FIG. 33, graft G is drawn upwardly through the cuff mountedon instrument 300 to located edge GE above the cuff, and above thefasteners 66 of the cuff. Then, as indicated by arrow 340, anvil 312 ismoved to orient hooks 338 in cutouts 310. This condition is shown inFIG. 34.

Side sections 322 and 324 are unitary, and each includes a fastenerturning area 343 and 345 located to engage fastener 66 when the anvil isoperated.

After the anvil is engaged with the instrument 300, movement of thethreaded element forces elements 322 and 324 downwardly until turningareas 343 and 345 engage the ends of fasteners 66. Further movement ofthe elements 322, 324, turns fasteners around to attach the cuff to thegraft vessel in the manner of a staple. Once the cuff is secured to thevessel, the anvil is released, and the cuff and attached vessel removedfrom the instrument 300. As will be understood from the abovediscussion, the fasteners 66 are evenly turned by the anvil to evenlymount the cuff to the graft. The cuffed graft can then be laid asideuntil it is needed.

An alternative form of an instrument used to mount a cuff on a graft isshown in FIGS. 35-37. The graft is prepared in the manner discussedabove.

End cuff attaching tool 350 includes a housing 352 having a formingcavity 354 defined therein to extend from end wall 356 adjacent to edgeforming elements 358 and 360. Housing 352 is slidably mounted on plate362 by a track 363 to be moved by hand pressure in directions 363' and363". Housing 364 is mounted on plate 362 and slidably receives apushrod 366. Pushrod 366 has a link 368 attached at one end thereof by apivot pin 370. Pushrod 366 can be operated by hand to move in directions372 and 374 as indicated by double-headed arrow 376.

A tilt table 380 is pivotally attached to the plate 362 by pivot pins,such as pin 382, and is pivotally attached to the link 368 by pin 384.As can be seen in FIG. 35, movement of the pushrod in direction 374tilts the table in direction 386 about pin 382, and vice versa forpushrod movement in direction 372. The table moves from the positionshown in FIG. 35A to the position shown in FIG. 35C under the influenceof this pushrod movement.

A vessel receiving element 390 is mounted on one end of the plate 362 toextend upwardly and outwardly therefrom at an angle as shown in FIG. 35.Table 380 includes a cutout section 392 which receives a cuff with cufftoe 394 on top and cuff heel 396 on the bottom. Table 380 includesalignment pins 398 that are received in alignment holes 400 on the cuff,and alignment holes 402 that receive alignment pins 404 on the cuff toreleasably secure the cuff to the table.

As can be seen in FIG. 35, shaft 390 will extend through thecuff-receiving section 392 and through the cuff mounted on the table.Graft G is placed over the shaft to extend through the cuff with end 406attached to hooks 408 on the table to temporarily mount the graft to theinstrument plate 362. Operation of the pushrod tilts the table indirection 386 to bring the cuff down on top of the graft as can beunderstood from FIGS. 36A, 36B and 36C. Once the cuff is in place asshown in FIG. 36C, the housing 352 is moved toward the end of the tablein direction 363" as shown in FIGS. 36C and 36D. The cuff and graft areguided into cavity 354 and the front end of the cuff and graft engagethe end of the cavity as indicated in FIGS. 36D and 37. The shaft 390includes fastener turning areas, such as area 410 and the turningmovement of the table forces cuff fasteners through the graft and intoengagement with the shaft at the turning areas. Further turning movementof the table turns the fasteners to couple the cuff to the graft.Movement of the housing 352 in direction 363" engages J-shaped fastener66' with the housing and forces that fastener through the graft and intoturning area 410. Further movement of the housing turns the fastener tocouple the cuff to the graft. Once the J-shaped fasteners are coupled tothe graft, the cuff is coupled to the graft and the housing can be movedin direction 363' and, table 380 moved opposite to direction 386. Thecuffed-graft can then be removed from the shaft 390. The J-shape offasteners 66' prevents the graft vessel from becoming damaged fromotherwise protruding pins from the cuff as the tilt-table is beingrotated. The variation in shape of the fasteners thus protects the graftvessel.

As before, once the graft vessel is cuffed, it can be set aside untilthe artery is cuffed.

Instrument for coupling one cuff to another Shown in FIGS. 38-40 is aninstrument that can be used to couple one cuff to another in thedouble-cuff form of the invention. As shown in FIG. 38, instrument 450is releasably attached to a vessel-mounted cuff, and is then operated toattach that cuff to another vessel-mounted cuff. One cuff can beattached to an artery using the instrument shown in FIG. 25 (usingelements 130, 132 and 136) while a cuff can be attached to a graft usingthe instrument shown in either FIG. 31 or FIG. 35 in an end-to-sideanastomosis, or using the instrument shown in FIG. 25 twice (usingelements 130, 132 and 136 to attach a cuff to an artery and usingelement 134 to attach a cuff to a graft) in a side-to-side anastomosis.

The two cuffs are attached together using instrument 450 shown in FIG.38. Instrument 450 includes a handle 452 having a hand-grip 454 on oneend thereof. A trigger housing 456 is mounted adjacent to the hand grip.An anchor element 458 is also mounted on the handle adjacent to the handgrip. A cuff engaging section 460 is mounted on the other end of thehandle and includes a base 462 having a forward end 464 and an aft end466. Cuff engaging C-shaped hooks 468 are pivotally mounted on the basesection by pivot bars, such as bar 470 extending through the hooks sothe hooks pivot in directions 472 and 474. Clamping hooks 476 and 478are also pivotally mounted on the base section by bars 470 to move inthe directions 472 and 474. Hooks 468 are spring biased in direction 474by springs, such as spring 480 and hooks 476 and 478 are fixed to bar470 for rotation therewith. Hooks 476 include cutout portions, such asportion 482. It is noted that a hook 478 is not shown in FIG. 38 but islocated on the base diametrically opposite to hook 478. Hooks 468 clampinstrument 450 to the cuff, and hooks 476 and 478 force the malefastening elements such as element 106 of one cuff through femaleelements, such as element 104, of the other cuff. For this reason, hooks476 include a cutout section to accommodate the male element, whereashooks 478 do not include a cutout section as these hooks engage thefemale elements.

The hooks are operated by hand. As shown in FIG. 38, hooks 468 areoperated by mechanism 490 which includes a tether 492 attached at oneend thereof to element 458 and at the other end thereof ears 494 on eachhook 468. Tether 492 extends through guide 496 which is located betweenthe ears 494. Therefore, movement of element 458 in direction 498 drawsears 494 together in directions 500' and 500" against the bias ofsprings 480. The springs tend to move the hooks into cuff engagingpositions, such as shown in FIG. 39, and the tether is operated torelease tool 450 from the cuff. The tool 450 is shown attached to avessel mounted cuff in FIG. 39.

Hooks 476 and 478 are operated by a system 504 which includes a tether506 attached at one end thereof to the trigger housing 456 and at theother end thereof to levers 506. The tether extends through guides 508.Levers 506 are pivotally mounted on the base section by pins 510 to movein direction 512 when the trigger housing is moved in direction 514. Thepivot pins 510 are fixed to rod 470 to rotate that rod in direction 512with the levers. Hooks 476 and 478 are fixed to the rod 470 for rotationtherewith, and rotation of the levers in direction 512 rotates the rod470 in direction 516. Rotation of the hooks 476 and 478 in direction 516moves those hooks from the FIG. 38 position to the cuff engagingposition shown in FIG. 40. Rod 470 is also spring biased by a torsionspring, so when the trigger housing is released, that rod will rotate torelease hooks 476 and 478 back into the FIG. 38 position.

After the tool is mounted to a cuff, that cuff is attached to the othercuff. The cuff and tool are moved adjacent to the other cuff, as shownin FIG. 39, and the two cuffs are brought together and coupled as abovedescribed.

Method

FIGS. 41, 42A and 42B represent the method of using the above-describedinstrument in performing an anastomosis according to the teaching of thepresent invention.

The following steps are used to effect the anastomosis of the presentinvention in the single cuff method.

The location of the anastomosis is determined.

The graft is pulled onto the graft anvil.

The graft is garroted to the graft anvil.

The graft and graft anvil are set aside.

Perform arteriotomy.

Button-hole artery anvil into interior lumen of the artery.

Dock the artery anvil to the instrument.

Cinch the fasteners joining the cuff to the artery.

Operate the instrument to open the arteriotomy to full length.

Open the driver heads and bend shape the cuff.

Detach the artery anvil from the instrument and remove the artery anvilfrom the artery.

Close the drivers to accept the graft anvil.

Dock the graft anvil to the instrument.

Cinch the fasteners joining the cuff to the graft (single cuff form), orthe cuff on the graft to the cuff on the artery (double cuffembodiment).

Release the graft garret.

Release the graft anvil from the instrument and tie off the graft end.

Open the shape of the anastomosis with the instrument.

Release the instrument from the cuff or cuffs.

The double cuff technique is shown in FIG. 42A for a side-to-sideanastomosis and in FIG. 42B for an end-to-side anastomosis.

It should also be understood that while the hemostatic medium is shownin the preferred embodiments, there may be certain uses, such asmentioned above, of the device that will not require the hemostaticmedium. The joining at lumens like fallopian tubes is one example. It istherefore contemplated that this disclosure will cover an anastomosismeans and method which omits the hemostatic medium. One example of thishemostatic medium-less anastomosis is shown in FIG. 43 in which thetissue pins are staggered in a manner that allows the approximation ofthe tissue in a sinuous junction line. This will mimic the type ofapproximation that sutures provide by interweaving from one side to theother. The sinuous junction SJ is shown in FIG. 43 as tissue pinsattached to an external malleable stent S. Tissue is shown as T.

It is further possible at that point to join the two stents withmaterials that are flexible but which still hold the edges inapproximation creating a living hinge between the two stents. Thejunction SJ will thus be a living hinge about which the two vessels canpivot or move. FIG. 43 shows a single cuff design with only one bridgebeing shown for the sake of clarity of disclosure, it being understoodthat other bridges, as discussed above, are also included in the FIG. 43embodiment. A double cuff design is shown in FIG. 45, with only onecoupling element being shown.

Although this invention has been disclosed and illustrated to show theanastomosis of small distal grafts, there are other surgical proceduresthat will benefit from this type of improvement as will occur to thoseskilled in the art based on the teaching of this disclosure. Forexample, a proximal graft attachment to aortic supply, an anastomosis ofother luminal structures such as, but not limited to, Fallopian tubesurethra, ureter, bile ducts, etc. can also be performed using the meansand method disclosed herein.

FIG. 46 shows the use of the present means and method as applied tomultiple grafts. As above discussed, where an existing blood supplyconduit, such as the IMA, is not available to use, an artificial supplyvessel must be grafted. Usually another vessel such as the saphenousvein is harvested from the patient's leg. At this point, the graft mustbe attached to a supply. This is usually the aorta AA. In the area abovethe aortic valve, a proximal anastomosis P is performed using thetechniques discussed above to attach the new supply conduit to theaorta. The means and method discussed above is used to perform thisprocedure. The means and method discussed above is also used to attachthe jump graft JG in an end-to-side manner ES in addition to theside-to-side manner SS shown. Multiple grafts are thus effected usingthe teaching of the present invention. As will be understood by thoseskilled in the art based on the teaching of the present disclosure, anyvessel that needs to be by-passed or joined use the techniques of thisinvention.

In addition, it is understood that while the invention is particularlywell suited for endoscopic use, it is in no way limited to suchapplication. This invention will work equally well in an "open" surgicalsetting. Accordingly, these situations are intended to be included inthe scope of the present invention.

It is understood that while certain forms of the present invention havebeen illustrated and described herein, it is not to be limited to thespecific forms or arrangements of parts described and shown.

We claim:
 1. An anastomotic device comprising:A) a first malleablemounting structure for mounting on a first vessel; B) a second malleablemounting structure for mounting on a second vessel; C) fastener meansfor fastening said first mounting structure to said second mountingstructure; and D) means in each mounting structure for maintaining themounting structure associated therewith in a selected shape so a desiredflow area and shape can be established at the junction of said first andsecond vessels.
 2. The anastomotic device defined in claim 1 whereineach mounting structure further includes means for mounting eachmounting structure on the vessel associated therewith adjacent to anincision in the vessel and for placing an inside edge of the firstvessel immediately adjacent to the incision in said first vessel inhealing contact with an inside edge of the second vessel immediatelyadjacent to the incision in said second vessel.
 3. The anastomoticdevice defined in claim 1 wherein said first and second vessels are inside-to-side contact with each other.
 4. The anastomotic device definedin claim 1 wherein said first and second vessels are in end-to-sidecontact with each other.
 5. The anastomotic device defined in claim 1wherein each of said first and second mounting structures includes aflexible body, and means for attaching said body to a vessel.
 6. Theanastomotic device defined in claim 5 wherein said means for attachingsaid body to a vessel includes retention means.
 7. The anastomoticdevice defined in claim 6 further including means for placing saidretention means in said vessel.
 8. The anastomotic device defined inclaim 7 wherein said means for placing said retention means includes ananvil.
 9. The anastomotic device defined in claim 8 wherein said anvilincludes a curved surface for turning staples.
 10. The anastomoticdevice defined in claim 1 wherein said means in each mounting structurefor maintaining the mounting structure in a selected shape includes asinuous stiffening element.
 11. The anastomotic device defined in claim1 wherein each mounting structure is mounted adjacent to an incision inthe vessel associated therewith and said flow area is larger than thearea of one of said vessels whereby said one vessel is enlarged whensaid mounting structures are fastened together.
 12. The anastomoticdevice defined in claim 11 wherein said means in each mounting structurefor maintaining the mounting structure in a selected shape enlarges theincision in one vessel and decreases the size of the incision in theother vessel.
 13. The anastomotic device defined in claim 1 furtherincluding means for defining a blood flow passage and located in one ofsaid vessels for maintaining blood flow in the one vessel while saidmounting structures are being mounted to said vessels and fastened toeach other.
 14. For use in connecting a first vessel to a second vessel,each vessel having an inside edge surface extending radially of a wallof the vessel, an anastomotic device comprising: means for placing theinside edge surface of the first vessel in abutting, healing contactwith the inside edge surface of of the second vessel so the vessels healtogether at the inside edge surfaces of the vessels, a stiffeningframework said stiffening framework being formed of deformable materialwhich causes said stiffening framework to remain in a secondconfiguration after being deformed from a first configuration, means onsaid stiffening framework for attaching said stiffening framework to theoutside surfaces of both the first and second vessels, said stiffeningframework holding the inside edge surfaces of the first and secondvessels in a first orientation when the stiffening framework is in oneconfiguration and causing the inside edge surfaces of the first andsecond vessels to be in healing contact with each other when thestiffening framework is in a second configuration.
 15. An anastomoticdevice comprising: a mounting structure for mounting on the outsidesurface of a first vessel adjacent to an incision and on the outsidesurface of a second vessel adjacent to an incision in the secondvessels, said mounting structure being formed of deformable materialthat cause it to retain a second configuration after being deformed froman first configuration, the outside surfaces being located outside thevessels after the incisions have healed.
 16. The anastomotic devicedefined in claim 15 further including means connecting said mountingstructure to said vessels in position so that an inside edge of saidfirst vessel immediately adjacent to the incision in said first vesselis in healing contact with an inside edge of said second vesselimmediately adjacent to the incision in said second vessel.
 17. Theanastomotic device defined in claim 16 wherein said first and secondvessels are in side-to-side contact with each other.
 18. The anastomoticdevice defined in claim 14 wherein said first and second vessels are inend-to-side contact with each other.
 19. The anastomotic device definedin claim 14 further including means for defining a blood flow passageand located in one of said vessels for maintaining blood flow in the onevessel while the inside edge of one vessel is being placed in abuttingcontact with the inside edge of the second vessel.
 20. The anastomoticdevice defined in claim 14 wherein each of said first and secondmounting structures includes a flexible body, and means for attachingsaid body to a vessel.
 21. The anastomotic device defined in claim 20wherein said means for attaching said body to a vessel includesretention means.
 22. The anastomotic device defined in claim 21 furtherincluding means for placing said retention means in said vessel.
 23. Theanastomotic device defined in claim 22 wherein said means for placingsaid retention means includes an anvil.
 24. The anastomotic devicedefined in claim 22 wherein said anvil includes a curved surface forturning said staples.
 25. The anastomotic device defined in claim 14wherein said means in each mounting structure for maintaining themounting structure in a selected shape includes a sinuous stiffeningelement.
 26. The anastomotic device defined in claim 14 wherein eachmounting structure is mounted adjacent to an incision in the vesselassociated therewith and said flow area is larger than the area of oneof said vessels whereby said one vessel is enlarged when said mountingstructures are fastened together.
 27. The anastomotic device defined inclaim 14 further including a blood flow passage defining means in one ofsaid vessels for maintaining blood flow while said mounting structuresare being mounted to said vessels and fastened to each other.
 28. Ananastomotic device comprising:A) a stent located on a vessel to bejoined to another vessel, said stent including a framework formed ofdeformable material that causes said framework to retain a secondconfiguration after it has been deformed from a first configuration; B)means for deforming said stent; and C) vessel attaching means on saidstent for attaching said stent to the outside surface of the vessel, andto position the inside surface of the vessel adjacent to the insidesurface of another vessel.
 29. The anastomotic device defined in claim28 further including a hemostatic medium.
 30. An anastomotic devicecomprising:A) a first malleable frame mounted on an outside surface of afirst vessel; B) a second malleable frame mounted on an outside surfaceof a second vessel; C) fastener means for fastening said first malleableframe to said second malleable frame; and D) means in each malleableframe for maintaining the malleable frame associated therewith in aselected shape so a desired flow area and shape can be established atthe junction of said first and second vessels.
 31. The anastomoticdevice defined in claim 30 further including a living hinge located at ajunction formed between the first and second vessels.
 32. Theanastomotic device defined in claim 30 wherein said fastener meansinclude tissue retention pins that are staggered with respect to eachother.
 33. The anastomotic device defined in claim 30 wherein thejunction formed between the two vessels is sinuous in shape.
 34. Theanastomotic device defined in claim 30 further including means foraligning and attaching said frames.
 35. An anastomotic devicecomprising: means for placing an inside edge surface of an incision in afirst vessel in abutting contact with an inside surface of an incisionin a second vessel so the vessels heal together at the inside edgesurfaces of the vessels, and a stiffening framework located on theoutside surface of each of the vessels and being fabricated of adeformable material that retains a second configuration after beingdeformed from a first configuration, means on said stiffening frameworkfor attaching said stiffening framework to said vessels.
 36. Theanastomotic device defined in claim 35 further including pins on saidmalleable frames and wherein the pins on the first frame are oriented instaggered relationship with respect to pins on the second frame tocompress tissue located between pins on opposing rings.
 37. Theanastomosis device defined in claim 35 further including a dockingsystem for connecting the stiffening framework on the first vessel tothe stiffening framework on the second vessel for producing a compliantjoint.
 38. The anastomotic device defined in claim 35 further includingtissue fastening means which includes pins which are arranged withrespect to each other to force tissue interposed between pins betweenthe frames.
 39. The anastomotic device defined in claim 28 wherein saidstent is located on the outside of the vessel.
 40. The anastomoticdevice defined in claim 28 wherein said vessel attaching means includesstaples.